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I am interested in how clinic based or freestanding infusion centers are compounding drugs.Â Are you 797 compliant?Â Do you have pharmacists, nurses or a mixture of both preparing?Â If nursing is mixing, do you have 1 nurse to mix and pass off to the infusionist, or does each nurse mix and administer their own?Â What therapies are you mixing: antibiotics, biologics, lypholized IVIG, iron, etc? I realize this may be determined by your state boards of pharmacy / nursing.

I can not answer your questions about how it is done in the real world, however I can tell you that USP Chapter <797> is a mandatory regulation. This means that you are required to meet this standard. The issue is that the only regulatory oversite is for pharmacies from the state board of pharmacy. So there is no one coming to inspect your clinic about this practice. The purpose of this regulation is to insure a sterile product. Given the number of infectious outbreaks in outpatient facilities, I would think that you would want to meet these regulations so there would be no question about your commitment to patient safety. The process that I am most familiar with is for a freestanding clinic to contract with an infusion pharmacy to provide all compounding services. I have been very concerned about some of the practices I have heard about in doctor's offices. I am eager to see how others are addressing this issue.

Lynn, you mention that the regulations are for pharmacies and that no one will visit the clinic ....... unfortunately this is not correct. I work in an Urgent Care center and infuse medications. The STATE did come and now we are in the process of trying to compliant with their wishes. Do they have the right to regulate an urgent care center that is not a pharmacy? What about infusion home care agencies (not VNA) that administer / compound Remicade of IVIG consisting of more than 3 packages ( i.e. med vials plus solution bag) even if pooled? Anthing and everything you can offer on this would be helpful. Thanks

Here in Denver it seems to go like this: Some of the free-standing infusion centers are physician owned and they compound on site. USP 797 enforcement is the responsibility of the state board of pharmacy. The pharmacy board has no jurisdiction over MDs unless they are employing a pharmacist. So if the MD, an RN, or one of his MAs is doing the compounding they are able to operate below the radar. At least that is how I understand it.

Yes, you are correct. They are below the level of an routine inspection. But are you saying that this is acceptable? Also this is a federal regulation intended to provide sterile solutions. So even though no one is looking over their shoulder, they can still be held accountable to this as a standard. It is sad that the only place this would occur is in a court of law.

Sorry to be a little delayed on this thread but we manage infusion suites in MD offices across the country and we do compound on site both with and without licensed pharmacies. The 797 regulations are a daily influence in our work and it is mandatory, not elective. It is correct that the pharmacy boards and 797 do not control the practice of MDs or RNs but it does regulate the compounding, storage and transportation of CSPs (compounded sterile products) and the is regardless of who is doing the compounding, storage or transporting.

I was trying to paste the actual excerpt from 797 but this web page does not allow pasting, likely to discourage spam, and it is too lengthy for me to type over right now but the 797 is very clear that regardless or who and where, if you mix you are governed by 797 regulations. The only exception is medications mixed for emergency or immediate use (administrations started within one hour of beginning of preparation).

To respond to your orignal question our sites vary in what they mix but all are compliant with the latest 797 revisions for the type of compounding they do. They vary from immediate use only sites to chemo. We do not handle blood products (IVIG excluded) or do unsterile to sterile compounding. Some sites have a licensed pharmacy on site, others do not and some use a central fill pharmacy if allowed by the state regulations.

Thanks Tony! USP 797 is mandated for all! Also USP 800 is coming and will be mandated. So if you deal with hazasdous drugs, you will have to pay attention to both now. Sad to say there is a lack of oversight for professionals other than pharmacists and pharmacies, but I would like to think that responsible professionals would not require that much oversight to do the right thing. Silly me! Lynn